FDA conducts safety review of Maxipime antibiotic

WASHINGTON The Food and Drug Administration is conducting a safety review of the drug Maxipime, an injectable antibiotic made by Bristol-Myers Squibb used to treat serious infections like pneumonia, according to money.cnn.com

The FDA decided to initiate the review after a study from the medical journal The Lancet suggested that patients on the drug had a higher rate of death compared with patients treated with other drugs in the same class of medications, known as B-lactams. The study also shows that patients with febrile neutropenia – a condition marked by fever and a significant drop in white blood cells – had a higher risk of death.

In a statement posted on its Web site, the FDA said it was working with Bristol-Myers “to further evaluate the finding of increased mortality in patients who received cefepime.” The agency also said it wants health-care professionals and patients to report side effects from the use of cefepime to the FDA’s MedWatch adverse event reporting system.

Tony Plohoros, a Bristol-Myers spokesman said, “We have reviewed safety data from our database as well as government databases to determine if there’s a change in the safety profile of cefepime and have concluded that the safety profile has not changed.”

U.S. sales of Maxipime totaled $107 million during the first nine months of 2007, according to Dow Jones.

Scientists in Oklahoma are hopeful about Alzheimer’s vaccine

OKLAHOMA CITY Oklahoma City scientists have developed a vaccine that could restrain or even thwart Alzheimer’s Disease, according to The Oklahoman online.

The vaccine, designed to fight dementia in the brain via the human immune system, could reach human clinical trials in three to four years, according to officials at the Oklahoma Medical Research Foundation.

“These results are extremely exciting,” said Jordan Tang, OMRF researcher who led the laboratory study that resulted in the vaccine. “They certainly show that this vaccination approach warrants additional investigation as a therapy for Alzheimer’s disease.”

The illness, a fatal, memory-robbing disease, affects several million Americans, including 70,000 Oklahomans. November is National Alzheimer’s Disease Awareness Month.

Results of OMRF’s vaccine research appeared in the Oct. 21 edition of The Journal of the Federation of American Societies for Experimental Biology. “This is the first time this type of Alzheimer’s vaccine has been produced anywhere. Other types of vaccines have been tried, but have failed,” OMRF spokesman Adam Cohen said.

Tang had pointed out that while the vaccine should be an addition to developments to cure the disease, rather than a substitution, the vaccine is still in its critical stages.

Back 2002, the pharmaceutical company Elan halted trials of a different vaccine after 15 patients suffered swelling of the central nervous system. OMRF president, Dr. Stephen Prescott, said he’s hopeful Tang’s work will avoid the pitfalls that weighed down Elan’s vaccine. “This vaccination stimulates the immune system more gently than previous Alzheimer’s vaccines, so we are optimistic about its prospects going forward,” he said.

Avastin study on pancreatic cancer effects mixed results

ZURICH , Switzerland A new late-stage study of Roche Holding’s Avastin, and its effectiveness to slow down or avert pancreatic cancer in patients, had mixed results, the company said Tuesday.

The Swiss drugmaker said that although the addition of its drug to a Tarceva-chemotherapy combination failed to prolong the lives of patients with advanced pancreatic cancer, certain subjects did have some benefits when using Avastin.

Roche said that the study, which included 607 patients, showed that adding Avastin prolonged the time patients lived without their cancer worsening, as well as adding safety benefits.

An earlier trial, the company said, utilizing the same experiment, concluded that the addition of Avastin had shown no benefit in the treatment of pancreatic cancer.

Roche, which sponsored the study known as AVITA, plans to further analyze the data to determine the extent of the benefit of adding Avastin to the Tarceva-chemotherapy combination. The new details that surfaced from the study will not be published, the drugmaker said.

Pancreatic cancer, deemed the most difficult form of cancer to treat, is frequently resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body. It leads to the shortest life expectancy of any major tumor.

Avastin, which hinders the growth of tumors by restraining their blood supply, was jointly developed with Genentech, a U.S. biotechnology company (majority-owned by Roche), and is seen as one of Roche’s most important drugs.

Financial experts believe Avastin will eventually become Roche’s best-selling drug, according to Dow Jones, since the drug is expected to be approved to treat several types of cancers.

Avastin was first approved in the U.S. in 2004 for the treatment of advanced colorectal cancer, and was approved for the treatment of lung cancer one year later. It is currently awaiting sanction for use in breast cancer. In Europe, it won approval for the treatment of advanced breast cancer and lung cancer earlier this year.

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The workshops, sponsored by McKesson, have been offered by the Alexandria, Va.-based organization for more than 20 years and are slated to take place June 8-10 in Denver, Colo., and Oct. 4-6 in Boston.

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